Rejection criteria

Rejection criteria for the ropes resulting in durability loss, are defined by the regulations character and number of wires broken strand breakes friction wear corrosion ... 

The second part of the requirement deals with inspection and test records, which are also covered in clause 4.10.5. The difference between these requirements is that clause 4.10.1 requires you to document the records to be established (in other words define ) in the quality plan or procedures and clause 4.10.5 requires you to produce the records defined in the quality plan or procedures. Your inspection and test procedures therefore need to specify or contain the forms on which you intend to record the results of the inspections and tests performed. The details are covered later in this chapter, but there are two types of record to be considered the record that shows which inspections and tests have been performed and the record that shows the results of these inspections and tests. One may be a route card, shop traveler, or document which acts as both a plan of what to do and a record of the progress made and the other may be a table of results with specified parameters and accept/reject criteria. 

Acceptance criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). 

Rejection Criteria. If composite specimen fails to conform to this specification, tbe lot represented shall be rejected... 

The most important aspects of data handling for potency assays and low-precision assays are that the data is handled by validated computer programs and that the acceptance and rejection criteria incorporated are clear and based upon statistical or proven (at validation) limits. 

A description of a system suitability test to be used prior to sample analysis, which will include acceptance/rejection criteria... 

Assay-specific acceptance and rejection criteria for a standard curve and QCs... 

Monitoring and control of suitable process and product characteristics during production and installation The approval of processes and equipment, as appropriate Engineering drawings and inspection plans stipulating the acceptance and rejection criteria... 

Establish test methods, test intervals, sampling, and accept/reject criteria. This point is critical for the success of the validation. The team must be careful to ascertain that... 

Clarke error grid analysis of a study of 15 diabetic rats showed the percentage of readings that fell into the clinically correct regions (Zones A and B) increased from 92% to 96% when applying the Z-score rejection criteria.38 During the long-term implantation (25 4 days), Z-score calculations removed 32% of the individual sensor data from six fully implanted four-sensor arrays.39... 

The EPA recommends that advisory recovery acceptance criteria of 70-130 percent be used until laboratory control limits become available (EPA, 1996a) however, many laboratories use arbitrary limits as data quality acceptance criteria. The arbitrary selection of acceptance criteria for accuracy and precision is a harmful practice on the part of the laboratory and the data user. Arbitrarily criteria that are too narrow lead to unnecessary data rejection criteria that are too wide damage data... 

A check on rejection criteria avoids developing a standard that is not fit for purpose, and includes a reasoned assessment of the costs relative to the benefits of the... 

The value of Q is 24/26 = 0.923, which exceeds Qc(90%) for N= 4. Should the value 16.46 be rejected If these four measurements were the only ones, one should certainly reject that value. Here however we have the benefit of much more information, and a glance at the rest of the data show that the range of values at Xj = 2.2 is reasonably representative. In applying rejection criteria or other statistical criteria, one must always take into account the context in which the criteria are given, and be careful to make the best possible use of all the data at hand. 

Inclusion or exclusion of outliers can significantly influence exposure assessments, and harmonized outlier rejection criteria are needed. The suitability of existing approaches (e.g. anything beyond three standard deviations is an outlier) to occupational exposure data sets, as well as the role of field study observations, needs to be considered. 

Daas, A.G.J. Miller, J.H.McB. Relationship between content limits, system suitability for precision and accep-tance/rejection criteria for assays using chromatographic 45. methods. Pharmeuropa 1999, 11 (4), 571-577. 

The best statistical acceptance/rejection criteria for immunoassay results have proved to be the use of confidence intervals for total measurement error (e.g., including both accuracy and precision) and equivalence testing procedures [15], and a 90% two-sided confidence interval has been proposed for the acceptance of immunoassay data [145]. Recoveries of 70-120% are considered acceptable according to US-EPA guidelines and the maximum permissible level of false negatives is 5% [38]. 

The development of specifications of each critical reagent or step in the manufacturing process and the determination degree of conformance with specifications is a practical way of establishing manufacturing control. The specifications should contain the acceptance or rejection criteria for the item tested and provide a reference for the technique for assessing the specification parameter. 

Selection of NDT technique, test parameters and definition of acceptance or rejection criteria are based on the following ... 

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